UMIN-CTR Clinical Trial

Basic information
Public title	Development of a predictive strategy for the detection of the patients with high risk for delirium
Acronym	Deep Study
Scientific Title	Development of a predictive strategy for the detection of the patients with high risk for delirium
Scientific Title:Acronym	Deep Study
Region	Japan

Condition
Condition	Malignant tumors
Classification by specialty	Medicine in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study designs to develop a predictive strategy for the detection of the patients with high risk for delirium by analyzing bloods obtained from the patients who are in palliative care wards at the stage before and after the delirium onset.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of factors associated with delirium onset.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients in palliative care unit 2) Patients who are not delirium at the time of hospitalization 3) Patients who can obtain consent form
Key exclusion criteria	1) Patients who are at Delirium at the time of hospitalization 2) Patient judged by the attending physician to be inappropriate
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Okawaki
Organization	Kawasaki Medical School
Division name	Clinical Oncology
Zip code	701-0192
Address	Matsushima 577, Kurashiki, Okayama
TEL	086-462-1111
Email	m.okawaki@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Okawaki
Organization	Kawasaki Medical School
Division name	Clinical Oncology
Zip code	701-0192
Address	Matsushima 577, Kurashiki, Okayama
TEL	086-462-1111
Homepage URL
Email	m.okawaki@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawasaki Medical School
Address	577 Matsushima, Kurashiki, Okayama
Tel	086-462-1111
Email	kmsrec@med.kawasaki-m.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 12 Month 20 Day
Date of IRB	2020 Year 02 Month 03 Day
Anticipated trial start date	2020 Year 02 Month 03 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 12 Month 20 Day
Last modified on	2022 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044406